A Trial to Determine the Safety and Anti-tumor Activity Profile of the Combination of Cetuximab and Concomitant Cisplatin Plus 5-Fluorouracil (5-FU) in Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma in Head and Neck

Inclusion Criteria:

* Signed written informed consent
* Inpatient
* Greater than or equal to (\>=) 18 years of age
* Histologically or cytologically confirmed diagnosis of SCCHN
* Recurrent and/or metastatic SCCHN not suitable for local therapy
* Presence of at least 1 measurable lesion identified either by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified WHO criteria
* Karnofsky performance status (KPS) \>= 80 percent at trial entry
* Neutrophils \>= 1.5\*10\^9 per liter (L), platelet count \>= 100\*10\^9 per L, and hemoglobin \>= 90 gram per liter (g/L)
* Total bilirubin less than or equal to (\<=) 2\*upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<=3\*ULN
* Serum creatinine \<=133 micromole per liter (mcmol/L)
* Serum calcium within normal range
* Effective contraception if procreative potential exists (applicable for both male and female subjects)

Exclusion Criteria:

* Prior systemic chemotherapy, except if given as part of a multimodal treatment which was completed more than 6 months prior to trial entry
* Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial entry
* Nasopharyngeal carcinoma
* Active infection (infection requiring IV antibiotics), including active tuberculosis, or known and declared human immunodeficiency virus (HIV)
* Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, cardiac failure or liver failure
* Uncontrolled hypertension defined as systolic blood pressure \>=180 millimeter of mercury (mmHg) and/or diastolic blood pressure \>=130 mmHg under resting conditions
* Pregnancy (absence to be confirmed by serum beta human chorionic gonadotrophin \[beta-HCG\] test) or breastfeeding
* Concomitant chronic systemic immune therapy or hormonal therapy as cancer therapy
* Other concomitant anticancer therapies
* Documented or symptomatic brain or leptomeningeal metastasis
* Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
* Medical or psychological condition that would not permit the subject to complete the trial or sign informed consent
* Known drug abuse (with the exception of alcohol abuse)
* Known hypersensitivity or allergic reaction against any of the components of the trial treatment
* Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or epidermal growth factor receptor (EGFR) targeting therapy
* Previous or current other squamous cell carcinoma (SCC)
* Evidence of previous other malignancy within the last 5 years
* Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such
* Intake of any investigational medication within 30 days before trial entry
* Legal incapacity or limited legal capacity
* Other significant disease that in the Investigator's opinion would exclude the subject from the trial